Senate Bill sb1654
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Florida Senate - 2005 SB 1654
By Senator Fasano
11-1306-05
1 A bill to be entitled
2 An act relating to veterinary drug
3 distribution; amending s. 499.01, F.S.;
4 requiring a veterinary drug distributor to
5 obtain a permit from the Department of Health
6 before distributing both veterinary legend
7 drugs and certain human drugs permitted by the
8 department; amending s. 499.0121, F.S.;
9 requiring a wholesale distributor of a
10 prescription drug to provide the recipient of
11 the drug with pedigree papers if such a drug is
12 intended for sale to a human recipient;
13 exempting drugs approved as human drugs sold
14 directly to veterinarians from the
15 pedigree-paper requirement; providing an
16 effective date.
17
18 Be It Enacted by the Legislature of the State of Florida:
19
20 Section 1. Subsection (1) of section 499.01, Florida
21 Statutes, is amended to read:
22 499.01 Permits; applications; renewal; general
23 requirements.--
24 (1) Prior to operating, a permit is required for each
25 person and establishment that intends to operate as:
26 (a) A prescription drug manufacturer;
27 (b) A prescription drug repackager;
28 (c) An over-the-counter drug manufacturer;
29 (d) A compressed medical gas manufacturer;
30 (e) A device manufacturer;
31 (f) A cosmetic manufacturer;
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Florida Senate - 2005 SB 1654
11-1306-05
1 (g) A prescription drug wholesaler;
2 (h) A veterinary prescription drug wholesaler;
3 (i) A compressed medical gas wholesaler;
4 (j) An out-of-state prescription drug wholesaler;
5 (k) A nonresident prescription drug manufacturer;
6 (l) A freight forwarder;
7 (m) A retail pharmacy drug wholesaler;
8 (n) A veterinary legend drug retail establishment;
9 (o) A medical oxygen retail establishment;
10 (p) A complimentary drug distributor; or
11 (q) A restricted prescription drug distributor; or.
12 (r) A veterinary drug distributor distributing both
13 veterinary legend drugs and certain human drugs permitted by
14 the department.
15 Section 2. Paragraph (f) of subsection (6) of section
16 499.0121, Florida Statutes, is amended to read:
17 499.0121 Storage and handling of prescription drugs;
18 recordkeeping.--The department shall adopt rules to implement
19 this section as necessary to protect the public health,
20 safety, and welfare. Such rules shall include, but not be
21 limited to, requirements for the storage and handling of
22 prescription drugs and for the establishment and maintenance
23 of prescription drug distribution records.
24 (6) RECORDKEEPING.--The department shall adopt rules
25 that require keeping such records of prescription drugs as are
26 necessary for the protection of the public health.
27 (f)1. Effective July 1, 2006, each person who is
28 engaged in the wholesale distribution of a prescription drug
29 intended for sale to a human recipient and who is not the
30 manufacturer of that drug must, before each wholesale
31
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Florida Senate - 2005 SB 1654
11-1306-05
1 distribution of such drug, provide to the person who receives
2 the drug a pedigree paper as defined in s. 499.003(31).
3 2. A repackager must comply with this paragraph.
4 3. The pedigree paper requirements in this paragraph
5 do not apply to compressed medical gases, or veterinary legend
6 drugs, or approved human drugs sold directly to veterinarians.
7 4. Each wholesale distributor of prescription drugs
8 must maintain separate and distinct from other required
9 records all statements that are required under subparagraph 1.
10 5. In order to verify compliance with subparagraph
11 (d)1., each manufacturer of a prescription drug sold in this
12 state must make available upon request distribution
13 documentation related to its sales of prescription drugs,
14 regardless of whether the prescription drug was sold directly
15 by the manufacturer to a person in Florida.
16 Section 3. This act shall take effect July 1, 2005.
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19 SENATE SUMMARY
20 Requires a veterinary distributor distributing both
veterinary legend drugs and certain human drugs permitted
21 by the Department of Health to obtain a permit before
operating. Requires a person who is engaged in the
22 wholesale distribution of a prescription drug to provide
the recipient of such drug with a pedigree paper if the
23 drug is intended for sale to a human recipient. Exempts
drugs already approved as human drugs sold directly to
24 veterinarians.
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CODING: Words stricken are deletions; words underlined are additions.